UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034235 |
|---|---|
| Receipt number | R000039023 |
| Scientific Title | Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy |
| Date of disclosure of the study information | 2018/09/21 |
| Last modified on | 2021/09/02 17:51:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy
Acronym
UC-CAD study
Scientific Title
Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy
Scientific Title:Acronym
UC-CAD study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy, and evaluate the efficacy of AI system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
a computer-assisted diagnosis support system as an artificial intelligence function to predict endoscopic pathological healing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
When observe using endocytoscope(NBI), take a biopsy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eligible patients
>who were diagnosed with Ulcerative Colitis,
>who need lower GI observation in their clinical coarse,
>who are 20 years of age or more
Key exclusion criteria
Patients are excluded if
>they have a history of radiation therapy to their abdomen,
>it is impossible to take a biopsy because of the blood disorders or under anticoagulant therapy,
>they reject to join this clinical study.
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Ogata |
Organization
Keio University Schoool of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
hogata@z8.keio.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Mutaguchi |
Organization
Keio University Schoool of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
ma.mutaguchi@gmail.com
Sponsor or person
Institute
Keio University Schoool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University Schoool of Medicine, Center for Diagnostic and Therapeutic Endoscopy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Syowa University Northern Yokohama Hospital
National University Corporation Tokyo Medical and Dental University
Nagoya university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Review Committee
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
0333531211
ma.mutaguchi@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
昭和大学横浜市北部病院
東京医科歯科大学医学部附属病院
名古屋大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039023
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
